Drug Evaluation After Marketing

TLDR

Post‑marketing drug evaluation for safety and efficacy is essential, yet current national systems are inadequate. Safety is assessed through non‑experimental research using flexible, routine data systems, while efficacy requires randomized, blinded experiments and can be expedited by standby study capabilities.

Abstract

After marketing, drugs should be evaluated for safety and for efficacy. Present national systems are inadequate for both tasks. Safety can be evaluated by means of nonexperimental research, whereas evaluation of efficacy in a variety of settings representing normal medical practice generally requires experiments, randomized and blinded. Research into safety requires the maintenance of routine, yet flexible, multipurpose data systems, different for established and newly marketed drugs. Ad hoc studies on safety and on efficacy can be mounted more swiftly and economically through the maintenance of "standby" capabilities, in addition to maximal use of resources outside the actual national system.